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Clinical Trials

MainTitle

A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002068

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: February 1990
History of Changes
Purpose

Purpose

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.

Condition Intervention
Meningitis, Cryptococcal
HIV Infections

Drug : Fluconazole
Drug : Amphotericin B

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria
Concurrent Medication:
Allowed:

  • Immunosuppressant therapy.
  • Antiviral therapy such as zidovudine.
  • Prophylaxis for Pneumocystis carinii pneumonia.

  • Concurrent Treatment:
    Allowed:
  • Radiation therapy for mucocutaneous Kaposi's sarcoma.

  • Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
  • No prior systemic antifungal therapy for cryptococcosis.
  • Relapse after prior therapy.
  • Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.

  • Prior Medication:
    Allowed:
  • Immunosuppressant therapy.
  • Antiviral therapy such as zidovudine.
  • Prophylaxis for Pneumocystis carinii pneumonia.

  • Exclusion Criteria
    Co-existing Condition:
    Patients with the following are excluded:
  • Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Comatose.
  • Unlikely to survive more than 2 weeks.

  • Concurrent Medication:
    Excluded within 4 weeks of study entry:
  • Greater than 1 mg/kg/wk amphotericin B.
  • Coumadin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.

  • Concurrent Treatment:
    Excluded:
  • Lymphocyte replacement.

  • Patients with the following are excluded:
  • Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Comatose.
  • Unlikely to survive more than 2 weeks.

  • Prior Medication:
    Excluded within 4 weeks of study entry:
  • Greater than 1 mg/kg/wk amphotericin B.
  • Coumadin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.

  • Prior Treatment:
    Excluded:
  • Lymphocyte replacement.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002068

Locations

United States, California
Davies Med Ctr
San Francisco, California, United States, 94114
United States, Delaware
Christiana Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
United States, Florida
Univ of South Florida
Tampa, Florida, United States, 33612
United States, Maryland
Univ of Maryland / Inst of Human Virology
Baltimore, Maryland, United States, 212011192
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
United States, Tennessee
Univ of Tennessee
Memphis, Tennessee, United States, 38163
Canada
Saint Michael's Hosp
Toronto, Ontario, Canada

Sponsors and Collaborators

Pfizer
More Information

More Information


Responsible Party: Pfizer  
ClinicalTrials.gov Identifier: NCT00002068   History of Changes  
Other Study ID Numbers: 012H  
  056-159B  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Meningitis
Cryptococcosis
Drug Therapy, Combination
Fluconazole
Flucytosine
Acquired Immunodeficiency Syndrome
Amphotericin B

Additional relevant MeSH terms:
HIV Infections
Meningitis
Meningitis, Cryptococcal
Fluconazole
Amphotericin B
Liposomal amphotericin B

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.